NeonateNCT07076992
Dilemma of Neonatal Circumcision in Egypt
A study testing Circumcision by Plastibell, Circumcision by Gomco and bone cutter circumcision with suture hemostasis (BCS), in people with Neonate and Circumcision, run by Tanta University at 1 site in Egypt.
Trial summary
The study aims to compare wound healing, wound healing complications, cosmetic outcome, and level of parental satisfaction amongst four techniques of neonatal circumcision. Read more about this study
- Who is it for?
- Ages Up to 3 months, men only
- Conditions the study is for
- Neonate, Circumcision
- What is being tested?
- Circumcision by Plastibell, Circumcision by Gomco and bone cutter circumcision with suture hemostasis (BCS),
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male infants less than 3 months old.
- Undergoing circumcision.
Who cannot join
- Male infants more than 3 months old.
- Infants with bleeding disorders.
- Neonates with hypospadias, epispadias, micropenis, disorders of sex development (DSD)
- Neonates with buried or webbed penis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Dilemma of Neonatal Circumcision in Egypt: A Comparative Randomized Study
The study aims to compare wound healing, wound healing complications, cosmetic outcome, and level of parental satisfaction amongst four techniques of neonatal circumcision.
Read the detailed description
Circumcision of a male child is the most common surgery performed globally. The prevalence of circumcision in this part of the world is over 80%, with the majority conducted in the neonatal period. The techniques of circumcision are diverse, and the method of circumcision may account for the differences in the outcome of the procedure.
Circumcision has complications like all surgical procedures. These typically include early complications such as leakage, hemorrhage, wound infection, pain, and swelling. However, more serious problems such as prolonged bleeding and amputation of the glans penis may also be encountered.
- Conditions
- Neonate, Circumcision
- Being tested
- Circumcision by Plastibell, Circumcision by Gomco, bone cutter circumcision with suture hemostasis (BCS),, bone cutter circumcision with bipolar diathermy hemostasis (BCB).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumcision by PlastibellProcedure or surgery
Patients will undergo circumcision by Plastibell (PB).
Circumcision by GomcoProcedure or surgery
Patients will undergo circumcision by the Gomco (GM).
bone cutter circumcision with suture hemostasis (BCS),Procedure or surgery
bone cutter circumcision with suture hemostasis (BCS),
bone cutter circumcision with bipolar diathermy hemostasis (BCB).Procedure or surgery
bone cutter circumcision with bipolar diathermy hemostasis (BCB).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients will undergo circumcision by Plastibell (PB). Receives: Procedure: Circumcision by Plastibell |
| Group 2 | Experimental | Patients will undergo circumcision by the Gomco (GM). Receives: Procedure: Circumcision by Gomco |
| Group 3 | Experimental | who underwent bone cutter circumcision with suture hemostasis (BCS) Receives: Procedure: bone cutter circumcision with suture hemostasis (BCS), |
| Group 4 | Experimental | who underwent bone cutter circumcision with bipolar diathermy hemostasis (BCB). Receives: Procedure: bone cutter circumcision with bipolar diathermy hemostasis (BCB). |
What is being measured
The primary outcome is the main question the study is designed to answer.
circumcision related pain assessment by NIPS
pain assessed during and post circumcision by NIPS
Measured: during and 2 hours post circumcision
Secondary outcomes (2)
Wound healing
Superficial wound healing will be assessed on the 7th post-operative day.
Measured: 7 days postoperatively
Parental satisfaction
Degree of parental satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start22 Jul 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonateStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ahmed Elmaadawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076992
- Sponsor's protocol ID
- 36264PR1075/1/25
- Status last verified
- Nov 2026
- First submitted
- 2 Jul 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dilemma of Neonatal Circumcision in Egypt: A Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT07076992
- Acronym / sponsor ID
- 36264PR1075/1/25
- Conditions
- Neonate, Circumcision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to compare wound healing, wound healing complications, cosmetic outcome, and level of parental satisfaction amongst four techniques of neonatal circumcision.
Detailed description
Circumcision of a male child is the most common surgery performed globally. The prevalence of circumcision in this part of the world is over 80%, with the majority conducted in the neonatal period. The techniques of circumcision are diverse, and the method of circumcision may account for the differences in the outcome of the procedure.
Circumcision has complications like all surgical procedures. These typically include early complications such as leakage, hemorrhage, wound infection, pain, and swelling. However, more serious problems such as prolonged bleeding and amputation of the glans penis may also be encountered.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Circumcision by PlastibellPatients will undergo circumcision by Plastibell (PB). |
| Group 2 | Experimental | Procedure: Circumcision by GomcoPatients will undergo circumcision by the Gomco (GM). |
| Group 3 | Experimental | Procedure: bone cutter circumcision with suture hemostasis (BCS),who underwent bone cutter circumcision with suture hemostasis (BCS) |
| Group 4 | Experimental | Procedure: bone cutter circumcision with bipolar diathermy hemostasis (BCB).who underwent bone cutter circumcision with bipolar diathermy hemostasis (BCB). |
Who may qualify
- Ages
- Up to 3 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male infants less than 3 months old.
- Undergoing circumcision.
Key exclusion criteria (4 listed)
- Male infants more than 3 months old.
- Infants with bleeding disorders.
- Neonates with hypospadias, epispadias, micropenis, disorders of sex development (DSD)
- Neonates with buried or webbed penis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circumcision by PlastibellPatients will undergo circumcision by Plastibell (PB). | Procedure or surgery | Group 1 |
| Circumcision by GomcoPatients will undergo circumcision by the Gomco (GM). | Procedure or surgery | Group 2 |
| bone cutter circumcision with suture hemostasis (BCS),bone cutter circumcision with suture hemostasis (BCS), | Procedure or surgery | Group 3 |
| bone cutter circumcision with bipolar diathermy hemostasis (BCB).bone cutter circumcision with bipolar diathermy hemostasis (BCB). | Procedure or surgery | Group 4 |
Primary outcome
circumcision related pain assessment by NIPS
Time frame: during and 2 hours post circumcision
pain assessed during and post circumcision by NIPS
2 secondary outcomes
Wound healing
Time frame: 7 days postoperatively
Parental satisfaction
Time frame: 4 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumcision by Plastibell, Circumcision by Gomco and bone cutter circumcision with suture hemostasis (BCS), in people with Neonate and Circumcision, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circumcision related pain assessment by NIPS (time frame: during and 2 hours post circumcision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.